Actemra Side Effects

Generic name: tocilizumab

Note: This document contains side effect information about tocilizumab. Some of the dosage forms listed on this page may not apply to the brand name Actemra.

Some side effects of Actemra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tocilizumab: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking tocilizumab (the active ingredient contained in Actemra) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with tocilizumab. Call your doctor right away if you have signs of infection such as:

• fever, flu symptoms, mouth and throat ulcers, weight loss, feeling very tired;

• sores in your mouth and throat or on your skin;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• purple or red pinpoint spots under your skin;

• cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

• pain or burning when you urinate.

Call your doctor at once if you have any of these other serious side effects:

• severe stomach pain with constipation;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• painful blistering skin rash with burning, itching, or tingly feeling; or

• upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of tocilizumab may include:

• runny or stuffy nose, sinus pain, sore throat;

• headache, dizziness;

• itching; or

• mild stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tocilizumab: intravenous solution

Respiratory

Respiratory side effects including upper respiratory tract infection (up to 8%), nasopharyngitis (up to 7%), and bronchitis (up to 4%) have been reported.

Nervous system

Nervous system side effects including headache (up to 7%) and dizziness (up to 3%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (up to 6%) have been reported.

Hepatic

Hepatic side effects including increased ALT (up to 6%) and increased transaminase levels (up to 2%) have been reported.

Dermatologic

Dermatologic side effects including rash (up to 4%) have been reported.

General

General side effects including upper abdominal pain (up to 3%) has been reported.

Gastrointestinal

Gastrointestinal side effects including mouth ulceration (up to 2%), gastritis (up to 2%), and gastrointestinal perforation have been reported.

Hypersensitivity

Hypersensitivity side effects including clinically significant hypersensitivity reactions (e.g., anaphylactoid and anaphylactic reactions) (up to 0.2%) associated with tocilizumab (the active ingredient contained in Actemra) and requiring treatment discontinuation have been reported. Postmarketing reports of hypersensitivity reaction and anaphylaxis including events with a fatal outcome have been reported.

Oncologic

Oncologic side effects including malignancies have been reported.

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